Introducing our free EHDS Readiness Assessment Tool
In this blog we introduce the free Aridhia EHDS Readiness Assessment tool. It allows all prospective Health Data Holders to understand their obligations under EHDS and provides a short report identifying any gaps in their current provision.
The tool does not require a login and we do not retain any of your data. You can try it out here.
EHDS Key Dates
The EHDS legislation:
It defines two types of data usage, primary which relates directly to patient care, and secondary where health data is reused for other purposes such as research, innovation, or public health policy-making.
The key dates for secondary use of data under EHDS are March 2027 when the EU Commission will provide detailed rules for operationalisation, and March 2029, when these rules will come into force for most data types. This means that Health Data Holders have a little over two years to ensure they are ready to comply with regulations around secondary use.
Key Articles for Health Data Holders:
The following articles of the legislation are the most immediately relevant to any potential Health Data Holders, and our assessment tool will help those impacted understand how particular articles relate to gaps in their current data management infrastructure.
Article 51 – details the types of data that should be made available for secondary use. This covers a wide variety of data types including electronic health records, genomic data, administrative data related to health, and data generated from medical devices.
Article 60 – details the duties of Health Data Holders, including their obligation to make appropriately formatted metadata for all of their data holdings available to their Health Data Access Body (HDAB).
Article 72 – introduces the distinction between standard Health Data Holders (HDH) and Trusted Health Data Holders (THDH). See below for more details.
Article 73 – provides the current EHDS definition for a Secure Processing Environment (SPE), the critical component of the proposed EHDS infrastructure where all data analysis will take place.
Article 77 – details the requirement that Health Data Holders provide their metadata in the approved format. This will be finalised in March 2027.
Trusted Health Data Holders:
As detailed above the legislation makes a distinction between standard Health Data Holders and Trusted Health Data Holders.
HDHs are only required to provide their HDAB with up to date metadata for all their data sets and to provide the underlying data when an access request is approved. However, they have no role in the approval process, and their data will be provisioned in any SPE approved by the HDAB.
THDHs can retain more control of their data. They can provide a recommendation for approval or rejection to their HDAB on all data permit applications. More importantly, when an application is approved a THDH can provision the data in their own SPE, meaning the data remains under their control.
Our assessment tool helps HDHs understand if they want to be a Trusted HDH, and also what they would need to do to achieve that status.
If you would like to know more about our work on EHDS please contact us here.